CTRI Number |
CTRI/2023/10/058985 [Registered on: 20/10/2023] Trial Registered Prospectively |
Last Modified On: |
05/10/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Effectiveness of brain Gym exercise in addition to balance training vs balance training in balance in Parkinson patients |
Scientific Title of Study
|
Effect of brain gym exercise along with balance training versus balance training on fear of fall and balance in patients with Parkinsonism |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Saylee Phatak |
Designation |
MPT student |
Affiliation |
sunandan divatia school of sciences |
Address |
Department of Physiotherapy, Ground Floor, Nanavati Super Specialty Hospital SV Road, Vile Parle(W)
Mumbai (Suburban) MAHARASHTRA 400056 India |
Phone |
7045837544 |
Fax |
|
Email |
sayuphatak@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sabah Thaver |
Designation |
Assisstant professor- physiotherapist |
Affiliation |
sunandan divatia school of sciences |
Address |
Sunandan Divatia School of Science ,Vile Parle West. Bhaktivedanta Road
Mumbai (Suburban) MAHARASHTRA 400056 India |
Phone |
9820691076 |
Fax |
|
Email |
Sabah.Thaver@nmims.edu |
|
Details of Contact Person Public Query
|
Name |
Dr Sabah Thaver |
Designation |
Assisstant professor- physiotherapist |
Affiliation |
sunandan divatia school of sciences |
Address |
Sunandan Divatia School of Science ,Vile Parle West. Bhaktivedanta Road
Mumbai (Suburban) MAHARASHTRA 400056 India |
Phone |
9820691076 |
Fax |
|
Email |
Sabah.Thaver@nmims.edu |
|
Source of Monetary or Material Support
|
Department of Physiotherapy ,ground floor, Nanavati Max SuperSpecality Hospital, sv Road, Vile parle west, |
|
Primary Sponsor
|
Name |
Dr. saylee phatak |
Address |
sunandan divate school of sciences svkm, bhaktivedanta road vile parle west 400056 |
Type of Sponsor |
Other [self ] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr ali irani |
Nanavati Max Super Specialty Hospital |
department of physiotherapy ground floor, Mumbai (Suburban) MAHARASHTRA |
02261347560
physiodept.nanavati@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Nanavati max super speciality hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Balance Training |
total 12 session
thrice a week |
Intervention |
Brain gym and Balance training |
Total 12 session
Thrice a week
|
|
Inclusion Criteria
|
Age From |
50.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Indivisual diagonosed with Parkinsons and withclinical score up to 4 on Modified Hoehn and Yahr scale |
|
ExclusionCriteria |
Details |
Indivisual with any other medical or recent surgical history which may prevent participation in study .
Indivisual with vision and auditory disorder.
Patients with cognitive challenges example :PD associated dementia. |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Fall Efficacy Scale - International |
Baseline ,post intervention and 1 month follow up |
|
Secondary Outcome
|
Outcome |
TimePoints |
mini BEST test |
Baseline and postintervention. |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
20/10/2023 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
TITLE OF STUDY : Effect of brain gym exercise along with balance training versus balance training on fear of fall and balance in patients with parkinsonism . INTRODUCTION : Parkinson’s disease is a progressive disorder of the central nervous system with both motor and non-motor symptoms that particularly affects movement. The clinical diagnosis of Parkinsonism is based primarily on motor features, such as a slowly progressive asymmetric resting tremor, rigidity and bradykinesia. Of all the symptoms Fear of Fall is often as the most stressful symptom. Factors affecting fear of fall are Postural instability , Balance impairment and Lack of confidence . this fear of fall leading to restriction in mobility, Reduced fuctional Ability ,Reduced Functional independence and Social isolation . Brain gym (Education Kinesthetics) is an intervention by Mr. Paul and Mrs. Dennison in 1970 which by facilitating optimal achievement of mental potential and helps in the removal of stress, thereby supporting success, self-confidence creativity, communication, and organization . It has been used in kids with a hyperactive vestibular system such as in ADHD, Autism Spectrum Disorders and Vestibular disorders to reduce their level of anxiety and stress. They consist of 26 activities easy movements that are though to boost communication among the many nerve cells and functional centres located through the body and brain and are simple, cost effective way of managing stress and anxiety in controlled manner. AIM: To determine the effect of brain gym exercise in addition to balance training versus balance training on fear of fall and balance in patients with parkinsonism . OBJECTIVE : - To evaluate the effect of balance exercises on fear of fall and balance on patients with Parkinson’s.
- To evaluate the effect of Brain Gym Exercises in adjunct to balance exercises on patients with Parkinson’s.
- To compare both the groups.
INCLUSION CRITERIA : Individuals diagnosed with Parkinson’s and with a clinical score upto 4 on Modified Hoehn and Yahr scale EXCLUSION CRITERIA : · Individuals with any other medical or recent surgical history which may prevent participation in study · Individuals with vision or auditory disorders. · Patients with cognitive challenges example: PD associated dementia. |